Combined Ablation Techniques for Ventricular Tachycardia

(DUAL-VT Trial)

Recruiting at 3 trial locations

Overseen By Atul Verma

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Disqualifiers: Heart failure, Myocardial infarction, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to treat ventricular tachycardia (a fast, irregular heart rhythm) by combining pulsed field and radiofrequency energy to enhance catheter ablation effectiveness. The goal is to determine if this approach can better control heart rhythm compared to current methods. Individuals who frequently experience these fast heartbeats, particularly those who have required medical intervention such as shocks from a heart device or hospital visits, might be suitable candidates.

As an unphased trial, this study provides patients the chance to contribute to innovative research that could lead to more effective treatments for heart rhythm issues.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What prior data suggests that this new ablation technology is safe for ventricular tachycardia?

In a previous study, over 17,000 patients treated with pulsed field ablation experienced fewer side effects, as it caused less harm to nearby tissues compared to traditional methods. Another study showed that using pulsed field energy along with radiofrequency energy successfully treated ventricular tachycardia without complications.

These findings suggest that the new ablation method under study is safe and well-tolerated in humans. Although the specific treatment in the trial is new, its components have been tested in many people with positive safety results. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combined pulsed field and radiofrequency energy treatment for ventricular tachycardia because it integrates two powerful ablation techniques into one device, potentially enhancing precision and effectiveness. Unlike standard treatments, which typically rely solely on radiofrequency energy, this approach also employs pulsed field ablation, a method that selectively targets heart tissue with electrical pulses, reducing the risk of damaging surrounding healthy tissue. This innovative combination aims to improve outcomes for patients by offering a more targeted and potentially safer option for managing ventricular tachycardia.

What evidence suggests that this combined ablation technique is effective for ventricular tachycardia?

Research has shown that combining pulsed field ablation (PFA) with radiofrequency (RF) ablation can effectively treat ventricular tachycardia (VT), a type of fast heart rhythm. PFA uses electric fields to destroy heart tissue cells, while RF uses heat for the same purpose. A study involving multiple centers found that PFA alone was successful 85% of the time over three months, with no major complications. Another study reported an 88.8% success rate with PFA, demonstrating 100% effectiveness in the long term with no return of VT. In this trial, participants will undergo a combined ablation technique using both PFA and RF, potentially improving these results by leveraging the strengths of both methods, as they work differently to treat the heart condition. ^{2 4 6 7 8}

Who Is on the Research Team?

Atul Verma, MD

Principal Investigator

McGill University Health Centre/Research Institute of the McGill University Health Centre

Are You a Good Fit for This Trial?

This trial is for individuals with types of abnormal heart rhythms known as nonsustained ventricular tachycardia and ventricular tachycardia. Specific eligibility criteria are not provided, but typically participants would need a confirmed diagnosis and may be required to meet certain health standards.

Inclusion Criteria

My heart's pumping ability is at least 30%.

Documented episodes assessment will be performed by a review of ECGs, hospitalization records, and/or Implantable Cardioverter Defibrillator (ICD) interrogation

Patients must have an ICD implanted

Exclusion Criteria

I am scheduled for a special heart mapping or treatment before my VT procedure.

I had a heart attack less than 2 months ago, but if I have ongoing VT, it's been at least 3 weeks.

I do not have tubes inserted into my heart chambers.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo catheter ablation of ventricular tachycardia using a novel combination ablation device

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Combined Pulsed Field and Radiofrequency Energy

Trial Overview The study is testing a new ablation technology that uses both pulsed field ablation and radiofrequency energy to treat irregular heartbeats in the lower chambers of the heart. It's a single-arm study, meaning all participants will receive this combined treatment approach.

How Is the Trial Designed?

Group I: Ablation group Experimental Treatment 1 Intervention

Patients in this single arm will all undergo clinically-indicated catheter ablation of ventricular tachycardia using a novel combination ablation device capable of delivering both radiofrequency and pulsed field ablation.

Who Is Running the Clinical Trial?

McGill University Health Centre/Research Institute of the McGill University Health Centre

Lead Sponsor

Trials

476

Recruited

170,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06816368

Study Details | NCT06816368 | Combined Pulsed Field ... Pulsed field (PF) energy, which causes cell death via irreversible electroporation and is non-thermal, may improve outcomes in patients with VT since it has ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666501825004052

Pulsed field ablation for ventricular arrhythmias A multicenter study using the CENTAURI™ system (Cardiofocus, Marlborough, MA) showed an 85% success rate over 3 months without major ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11442986/

Pulsed‐Field Ablation in Management of Ventricular ... Eight (88.8%) of procedures were successful with 100% long‐term efficacy. No procedural complications or ventricular tachycardia (VT) recurrence ...

4. academic.oup.com academic.oup.com/europace/article/27/9/euaf161/8220664

Pulsed field ablation for ventricular tachycardia: are we there ... This platform combines a lattice-tip catheter with a mapping/ablation console capable of delivering both PFA and RF energy.

5. heartrhythmcasereports.com heartrhythmcasereports.com/article/S2214-0271(25)00025-9/fulltext

De novo ventricular tachycardia ablation with stacked ... Pulsed field energy can be successfully applied to acute RF lesions in the ventricle without complications. · Combining RF and PF energy in the ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1050173825001008

Safety and outcomes of pulsed field ablation in the ... PFA demonstrated a high acute procedural success rate of 97.6 %. Success rates varied by SVT type: AVNRT (99.8 %), AVRT (98.7 %), and AT (96.1 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12242989/

De novo ventricular tachycardia ablation with stacked ... Pulsed field energy can be successfully applied to acute RF lesions in the ventricle without complications. •. Combining RF and PF energy in the ablation of VT ...

8. nature.com nature.com/articles/s41591-024-03114-3

Safety of pulsed field ablation in more than 17000 patients ... These data indicate that PFA demonstrates a favorable safety profile by avoiding much of the collateral damage seen with conventional thermal ablation.